Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR

FDA recall notice · announced August 28, 2013 · Earthlabs, Inc. Dba Wise Woman Herbals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products

Notes

Distribution: Nationwide
Lot/code information: Lot# 10010 Best used by: 07/14/13 Lot# 10285 Best used by: 02/16/14 Lot# 10640 Best used by: 11/09/14 Lot# 11107 Best used by: 09/16/15 Lot# 11408 Best used by: 05/04/16 Lot# 11711 Best used by: 11/23/16 Lot# 12088 Best used by: 09/04/17 Each lot number has various sizes Product numbers - 1EDCO, 2EDCO, 4EDCO, 8EDCO, 16EDCO, 32EDCO 1 (indicates package size) ED (indicates Eyebright) CO (indicates compound (blended from other finished products) Container sizes - Stock: 1 oz., 2 oz., 4 oz. Non-stock: 8 oz., 16 oz., 32 oz.
Quantity: 581x1oz bottles, 263x2 oz bottles, 20x4 oz bottles, 2x8 oz bottles, 1x16 oz bottle, 1x32 oz bottle
Status: Terminated
Products in this recall event:
- Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR (D-912-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.